Back to results

A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Primary Purpose

Hypertriglyceridemia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

1-Methylnicotinamide (1-MNA)

Placebo

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients at least 18 years of age at the time of informed consent (women of childbearing potential must be practicing adequate contraception)
Patients with mean serum TG > 200 mg/dl (2.26 mmol/l) and < 700 mg/dl (7.91 mmol/l) as measured at 2 sequential visits during the dietary controlled baseline period (Visits 2 and 3 or Visits 3 and 3a) and having lower level within 25% of upper level (higher value minus lower value)/higher value < 0.25)
Patients willing and able to sign an informed consent form and follow the protocol

Exclusion Criteria:

Patients who are pregnant or nursing
Patients with evidence of hepatic (ALT or AST greater than 1.5 ULN, bilirubin greater than 1.5 ULN, or cirrhosis) or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase
Patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l or HbA1C above 10%) as measured during the baseline phase
Patients with hypothyroidism that is not treated or not stable for at least 6 months prior to study entry
Patients with uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 110 mm Hg)
Patients with systolic blood pressure above 140 mm Hg AND three or more of the following cardiovascular risk factors:
- Current cigarette smoker
- HDL-C < 40 mg/dL (1.04 mmol/L)
- Coronary heart disease in male first degree relative < 55 years of age
- Coronary heart disease in female first degree relative < 65 years of age
- Male age 45 years or older
- Female age 55 years or older
Patients with known hyperuricemia or with a history of gout
Patients with an active peptic ulcer
Patients with known coronary artery disease, cerebrovascular disease or peripheral arterial disease that has previously required PCI or surgical intervention
Patients with known intolerance or allergy to niacin
Patients consuming more than 10 alcoholic drinks per week
Patients with a history of drug abuse
Patients receiving any lipid modifying agent within 4 weeks of entry into the baseline period
Patients participating in another clinical trial within 30 days of entry into the baseline period
Patients considered to be non-compliant to study medication (< 80% study medication) or diet during the placebo-baseline phase
Patients for whom the investigator determines that the study would not be appropriate

Sites / Locations

Institut de Cardiologie de Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

three placebo capsules PO three times daily.

1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily

1-MNA 270 mg daily: three active treatment capsules PO three times daily.

Outcomes

Primary Outcome Measures

The percent change in total serum Triglycerides from baseline to end of study

Secondary Outcome Measures

The percent change in total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, high-density lipoprotein cholesterol , total apolipoprotein B , apolipoprotein A1 and TG/HDL-C ratio from baseline to end of study.

Full Information

NCT ID

NCT00519714

First Posted

August 21, 2007

Last Updated

February 20, 2020

Sponsor

Montreal Heart Institute

Collaborators

Commonwealth Medical Clinic, Institut de Recherches Cliniques de Montreal, Clinique des maladies lipidiques de Québec, Centre de médecine genique communautaire, Omnispec clinical research Inc, Manna Research, St. Jerome Medical Research Inc., Royal Victoria Hospital, Canada, Hotel Dieu Hospital, St Michael's Hospital Health Center, Cambridge Cardiac Care Centre, Maritime Research Center, Rhodin Recherche Clinique, Queen Elizabeth II Health Sciences Centre, First Line Medical Ltd, Diabetes Research, Vancouver General Hosp, The Allin Clinic, St Paul's Hospital Healthy Heart Clinical Trial, The Clinical Trials Centre, Recherche Invascor Inc, MSHJ Research Associates, Dr.Kim W Tan

1. Study Identification

Unique Protocol Identification Number

NCT00519714

Brief Title

A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Montreal Heart Institute

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) > 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg 1-MNA or 90 mg 1-MNA three times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period. Additionally, blood samples will be drawn at randomisation and at clinic visits during the active treatment period for sparse sampling population pharmacokinetic assessments. All blood samples for lipid assessments and glucose measurements will be collected following a 12-hour fast. Safety and tolerability will be assessed throughout the trial through the evaluation of physical exams, ECGs, routine hematology and blood chemistry testing, and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

three placebo capsules PO three times daily.

Arm Title

Arm Type

Active Comparator

Arm Description

1-MNA 90 mg daily: one active treatment capsule and two placebo capsules PO three times daily

Arm Title

Arm Type

Active Comparator

Arm Description

1-MNA 270 mg daily: three active treatment capsules PO three times daily.

Intervention Type

Dietary Supplement

Intervention Name(s)

1-Methylnicotinamide (1-MNA)

Other Intervention Name(s)

1-MNA

Intervention Description

Following a 6-8-week placebo and dietary-controlled baseline period, 195 men and women will be randomized to receive placebo, 30 mg MNA or 90 mg MNA three times daily for twelve weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

The percent change in total serum Triglycerides from baseline to end of study

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients at least 18 years of age at the time of informed consent (women of childbearing potential must be practicing adequate contraception) Patients with mean serum TG > 200 mg/dl (2.26 mmol/l) and < 700 mg/dl (7.91 mmol/l) as measured at 2 sequential visits during the dietary controlled baseline period (Visits 2 and 3 or Visits 3 and 3a) and having lower level within 25% of upper level (higher value minus lower value)/higher value < 0.25) Patients willing and able to sign an informed consent form and follow the protocol Exclusion Criteria: Patients who are pregnant or nursing Patients with evidence of hepatic (ALT or AST greater than 1.5 ULN, bilirubin greater than 1.5 ULN, or cirrhosis) or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase Patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l or HbA1C above 10%) as measured during the baseline phase Patients with hypothyroidism that is not treated or not stable for at least 6 months prior to study entry Patients with uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 110 mm Hg) Patients with systolic blood pressure above 140 mm Hg AND three or more of the following cardiovascular risk factors: Current cigarette smoker HDL-C < 40 mg/dL (1.04 mmol/L) Coronary heart disease in male first degree relative < 55 years of age Coronary heart disease in female first degree relative < 65 years of age Male age 45 years or older Female age 55 years or older Patients with known hyperuricemia or with a history of gout Patients with an active peptic ulcer Patients with known coronary artery disease, cerebrovascular disease or peripheral arterial disease that has previously required PCI or surgical intervention Patients with known intolerance or allergy to niacin Patients consuming more than 10 alcoholic drinks per week Patients with a history of drug abuse Patients receiving any lipid modifying agent within 4 weeks of entry into the baseline period Patients participating in another clinical trial within 30 days of entry into the baseline period Patients considered to be non-compliant to study medication (< 80% study medication) or diet during the placebo-baseline phase Patients for whom the investigator determines that the study would not be appropriate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Claude Tardif, MD

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cardiologie de Montreal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

We'll reach out to this number within 24 hrs